This study is a prospective single arm open label intervention study over 16 weeks using the DHFS and a telemedicine platform with persons living with HIV who are not virologically suppressed, admitted to UCSD Hillcrest Medical Center and initiating or restarting anti-retroviral therapy (ARVs). This proof of concept study will investigate the feasibility of using the DHFS in hospitalized individuals living with HIV to support ARV adherence. The Study intervention has an initiation phase of 2 weeks, a persistence phase of 14 weeks and a follow-up phase out to 48 weeks. Once study consent is obtained, the participant will receive a focused case navigation, psychiatric and substance abuse evaluation and will initiate digitized ARVs, either in hospital or at the AVRC within 14 days of hospital discharge, in collaboration with their providers. The study intervention will be considered to start from the point at which the DHFS is started. The study team will ensure the participants continue to utilize the DHFS both in hospital and after discharge. Following the 16 week intervention the study team will continue to follow participants to evaluate retention in care and viral suppression up to 48 weeks in collaboration with the outpatient care providers.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
16
We will investigate the feasibility of using the DHFS in hospitalized individuals living with HIV to support ARV adherence.
UCSD AntiViral Research Center
San Diego, California, United States
An accurate measure of medication taking adherence captured by the DHFS
The number of doses ingested as captured by the DHFS over the number of doses prescribed, adjusted for positive detection accuracy (PDA). The system positive detection accuracy (PDA), based on prior studies, will allow an accurate measure of adherence with CI calculated.
Time frame: 16 weeks
Achieving <90% adherence as detected by DHFS over the study intervention (weeks 0-16).
Participants with \<90% adherence as detected by DHFS over the study intervention will be identified.
Time frame: 16 weeks
Percentage of participants who require adherence support to maintain adherence over 90% during weeks 0-16.
Percentage of participants who require adherence support to maintain adherence over 90% will be calculated.
Time frame: 16 weeks
Satisfaction rating for DHFS use for HIV treatment as 'satisfactory' or higher.
Characterize participant responses to study questionnaires on usability and exit questionnaire and summarize information regarding patient experience with the DHFS.
Time frame: 16 weeks
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